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astm-d6125-evaluation-of-skin-sensitization-using-in-vitro-models
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

ASTM D6125 Evaluation of Skin Sensitization Using In Vitro Models Laboratory Testing Service: A Comprehensive Guide

The ASTM D6125 standard is a widely recognized international standard for evaluating skin sensitization using in vitro models. This testing service is essential for ensuring the safety and efficacy of various products, including cosmetics, pharmaceuticals, and industrial chemicals.

Relevant Standards

  • ASTM D6125: Evaluation of Skin Sensitization Using In Vitro Models

  • ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

  • EN 71: Safety of toys - Part 2: Specific requirements for safety of certain toys (includes requirements for skin sensitization testing)

  • TSE: Turkish Standards Institution, equivalent to ISO standards

    • Legal and Regulatory Framework

    The use of in vitro models for evaluating skin sensitization is governed by various international and national regulations. The following are some key regulatory frameworks:

  • EU Cosmetics Regulation (EC 1223/2009): Requires safety testing, including in vitro models, for cosmetic products

  • US FDA: Requires safety testing, including in vitro models, for pharmaceuticals and cosmetics

  • REACH Regulation (EC 1907/2006): Requires registration and safety assessment of chemical substances, including skin sensitization testing

    • Standard Development Organizations

    The development and maintenance of standards are the responsibility of standard development organizations (SDOs) such as:

  • ASTM International: Develops and publishes technical standards for various industries

  • ISO (International Organization for Standardization): Develops and publishes international standards

  • EN (European Standards): Develops and publishes European standards

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulatory requirements, or emerging scientific evidence. This ensures that testing methods remain relevant and effective.

    Specific Standard Numbers and Scope

  • ASTM D6125: Covers the evaluation of skin sensitization using in vitro models for various products

  • ISO 10993-10: Covers the biological evaluation of medical devices, including tests for irritation and skin sensitization

    • Industry-Specific Compliance Requirements

    Compliance with standards is mandatory for certain industries:

  • Cosmetics industry: Must comply with EU Cosmetics Regulation (EC 1223/2009)

  • Pharmaceuticals industry: Must comply with US FDA regulations

  • Chemical industry: Must comply with REACH Regulation (EC 1907/2006)

    • Business and Technical Reasons for Conducting ASTM D6125 Testing

    Conducting ASTM D6125 testing is essential for various business and technical reasons:

  • Product safety and efficacy: Ensures the product does not cause skin irritation or sensitization

  • Regulatory compliance: Meets international and national regulatory requirements

  • Risk assessment and mitigation: Identifies potential risks associated with skin sensitization

  • Quality assurance and control: Demonstrates a commitment to quality and safety

    • Consequences of Not Performing This Test

    Failing to conduct ASTM D6125 testing can lead to:

  • Regulatory non-compliance

  • Product recalls or bans

  • Reputation damage

  • Financial losses

    • Industries and Sectors Requiring This Testing

    This testing is required for various industries and sectors, including:

  • Cosmetics industry: For skin care products, fragrances, and colorants

  • Pharmaceuticals industry: For topical and oral medications

  • Chemical industry: For industrial chemicals and cleaning agents

    • Risk Factors and Safety Implications

    Skin sensitization can lead to various health issues, including:

  • Allergic contact dermatitis

  • Irritant contact dermatitis

  • Phototoxicity

    • Testing Equipment and Instruments Used

    The following equipment is used for conducting ASTM D6125 testing:

  • Cell culture incubators: Maintains optimal temperature and humidity conditions

  • Microscopes: For cell viability and morphology assessment

  • ELISA readers: For detecting cytokine responses

    • Sample Preparation Procedures

    Samples are prepared according to the standards guidelines, which include:

  • Sample collection: Collecting cells or tissue samples from subjects

  • Cell culture: Establishing cell cultures in vitro

  • Treatment: Exposing cells to test substances

    • Testing Parameters and Conditions

    The following parameters and conditions are used for testing:

  • Concentration range: Test substance concentrations are varied to assess skin sensitization potential

  • Incubation time: Cells are incubated for a specified period to allow for cytokine responses

    • Measurement and Analysis Methods

    Cytokine responses are measured using ELISA or other suitable methods.

    Data Interpretation

    Data is interpreted according to the standards guidelines, which include:

  • Threshold values: Identifying threshold values for skin sensitization potential

  • Statistical analysis: Performing statistical analysis to determine significance

    • Interpretation of Results

    Results are interpreted according to the following criteria:

  • Positive: Indicates a potential risk of skin sensitization

  • Negative: Indicates no risk of skin sensitization

    • Validity and Reliability of Results

    The validity and reliability of results are ensured through:

  • Quality control measures

  • Regular calibration and maintenance of equipment

  • Blind testing

    • This concludes the comprehensive guide to ASTM D6125 evaluation of skin sensitization using in vitro models.

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